NCT05443217

Relationship Between Microbiota and Prognosis of Hepatocellular Carcinoma(HCC) After Systemic Treatments

Intestinal and Oral Microbiota Signatures of Clinical Response and Adverse Events in HCC Treated With Systemic Therapies

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

By tracking the short-term and long-term results of HCC patients treated with systemic therapies,the difference of microbiota between responded patients and non-responded patients was analyzed, and the correlation between gut and oral microbiota and short-term and long-term results was explored, so as to improve people's awareness of microbiota and pay attention to its prevention and treatment.

Detailed description

The investigators consecutively admit patients the questionnaire and collect the fecal. And by tracking the short-term and long-term outcomes of HCC patients treated with systemic therapies,the difference of gut microbiota between responded patients and non-responded patients is analyzed, and the correlation between gut and oral microbiota and short-term and long-term results is explored.Adverse events (AE) are recorded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 4.0).Tumor response is mainly evaluated by experienced hepatologists using radiological method within 4-12 weeks after treatments according to the RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST).Overall survival (OS) and Progression-free survival (PFS) are recorded.

Conditions

• Liver Cancer
• Microbiota
• Adverse Event
• Prognosis
• Efficacy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	questionnaire survey	All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-07-05
• Last updated: 2023-09-13

Locations

1 site across 1 country: China